Atlas FDA

ALARIS SYSTEM WITH GUARDRAILS SUITE MX

FDA 510(k) clearance K133532 · decided 2014-08-21

Clearance details

K-number
K133532
Device name
ALARIS SYSTEM WITH GUARDRAILS SUITE MX
Applicant
Carefusion 303, Inc.
Decision
Substantially Equivalent
Date received
2013-11-18
Decision date
2014-08-21
Days to decision
276 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit recall (Z-1645-2026)CareFusion 303, Inc.2026-03-26
BD Alaris PCU REF 8015 recall (Z-0184-2024)CareFusion 303, Inc.2023-11-07
BD Alaris Syringe Module, REF 8110 recall (Z-0185-2024)CareFusion 303, Inc.2023-11-07
Alaris PCA Module 8120 recall (Z-0186-2024)CareFusion 303, Inc.2023-11-07
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service recall (Z-2204-2021)BioMedical Equipment Service Co (BMES)2021-08-06
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bez recall (Z-1543-2021)STEP-HAR MEDICAL LLC2021-05-10
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bez recall (Z-1331-2021)Tenacore LLC2021-04-02
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 recall (Z-1332-2021)Tenacore LLC2021-04-02
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Mo recall (Z-2882-2020)CareFusion 303, Inc.2020-09-04
Alaris System PC Unit Model 8015 recall (Z-2909-2020)CareFusion 303, Inc.2020-09-04
PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015L recall (Z-2910-2020)CareFusion 303, Inc.2020-09-04
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare c recall (Z-2822-2020)CareFusion 303, Inc.2020-08-19
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcar recall (Z-2823-2020)CareFusion 303, Inc.2020-08-19
Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare ca recall (Z-2824-2020)CareFusion 303, Inc.2020-08-19
Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare recall (Z-2825-2020)CareFusion 303, Inc.2020-08-19
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide train recall (Z-2826-2020)CareFusion 303, Inc.2020-08-19
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system recall (Z-2716-2020)CareFusion 303, Inc.2020-08-06
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system recall (Z-2717-2020)CareFusion 303, Inc.2020-08-06
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system recall (Z-2718-2020)CareFusion 303, Inc.2020-08-06
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system recall (Z-2719-2020)CareFusion 303, Inc.2020-08-06
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system recall (Z-2720-2020)CareFusion 303, Inc.2020-08-06
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system recall (Z-2721-2020)CareFusion 303, Inc.2020-08-06
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring syste recall (Z-2722-2020)CareFusion 303, Inc.2020-08-06
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system recall (Z-2723-2020)CareFusion 303, Inc.2020-08-06
Alaris Pump Module Model 8100 recall (Z-2736-2020)CareFusion 303, Inc.2020-08-06
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system recall (Z-2740-2020)CareFusion 303, Inc.2020-08-06
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system recall (Z-2741-2020)CareFusion 303, Inc.2020-08-06
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) recall (Z-1359-2020)CareFusion 303, Inc.2020-03-05
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic recall (Z-1768-2019)CareFusion 303, Inc.2019-07-16